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PubMed2005

Respimat Soft Mist inhaler versus hydrofluoroalkane metered dose inhaler: patient preference and satisfaction.

INTRODUCTION: In addition to offering favorable pharmaceutical performance, an ideal inhaler should be well accepted by patients, as this may facilitate compliance. We report a study that specifically assessed inhaler preference in patients with obstructive lung disease after treatment with ipratropium bromide/fenoterol hydrobromide (Berodual delivered via either Respimat Soft Mist Inhaler (SMI) or hydrofluoroalkane metered dose inhaler (HFA-MDI). METHODS: Patients with COPD, asthma or mixed disease were randomized to receive ipratropium bromide/fenoterol hydrobromide 20/50 microg via Respimat SMI or 40/100 microg via HFA-MDI for 7 weeks each, in a crossover design. Patients were trained in inhaler use and given < or =5 attempts to demonstrate satisfactory technique. At the end of each treatment period, patients completed a 15-item satisfaction questionnaire, and inhaler technique was re-tested. On study completion, patients were asked which inhaler they preferred and they rated their willingness to continue using each inhaler. Clinical efficacy outcomes were measured by diary card to check whether switching inhaler affected efficacy. RESULTS: In total, 245 patients were randomized and 224 used both inhalers within their respective treatment periods. Of 201 patients expressing a preference, 162 (81%) preferred Respimat SMI and 39 (19%) preferred HFA-MDI (p < 0.001). Patients would rather continue using Respimat SMI than HFA-MDI (p < 0.001). Mean scores for 13 of the 15 satisfaction questions were significantly higher for Respimat SMI than HFA-MDI (p < 0.05); in addition, the total score was also significantly higher for Respimat SMI (p < 0.001). Most patients (217/224; 97%) were judged to have good technique with Respimat SMI after 7 weeks' use. Differences in efficacy measures between the devices were not significant. CONCLUSION: These data indicated that a large majority of patients preferred Respimat SMI to HFA-MDI.

Aerosols↗
PubMed1992

Kinetics of action of salbutamol inhaled from a metered dose inhaler (MDI) and a "Diskhaler".

In a double-blind cross-over study, 12 patients with reversible airways obstruction were treated with 200 micrograms salbutamol base in aerosol or 400 micrograms of powder following methacholine-induced bronchoconstriction. Salbutamol was inhaled either from a conventional metered dose inhaler (MDI) or from an inhaler (Diskhaler) utilizing the powdered form of the drug. The efficacy of both forms was identical whether assessed in terms of FEV1 or vital capacity. The ratio of the increase in FEV1 or vital capacity after bronchodilatation to the decrease during the prior bronchoconstriction was 1.4, indicating that both FEV1 and vital capacity improved over baseline following bronchodilatation. In six subjects, the onset of action of the powder form was more rapid, and in four the MDI acted more rapidly. In the group as a whole, the mean time constant for the action of salbutamol was identical (3.8 min) for the two forms. It is concluded that salbutamol powder has a similar efficacy and time course of action as the aerosol, probably because both formulations produce similar sized particles of the drug.

Administration, Inhalation↗
PubMed1996

[Evaluations of a specified number of inhalations and how to assess the contents in metered-dose inhalers].

Many kinds of Metered-Dose Inhalers (MDI) have been clinically available for bronchial asthma. Although manufacturers demonstrate the specified number of inhalations per canister on an attached document or on a plastic bag, the information provided are usually inadequate and inconsistent. They provide no information on the problems of the Metered-Dose Inhalers beyond the maximum specified number of actuations and the time when to exchange for a new one. We examined the technique how to evaluate the contents of MDI and their accuracy. Patients and their parents depended on inaccurate methods, such as shaking the inhalers to listen to the sound of contents, estimating the weight of the canisters and the size of emissions, and only a half of them were able to distinguish between 1/3 and 2/ 3 of remaining doses. Three Metered-Dose Inhalers with anti-inflammatory drugs and one MDI with beta-stimulant supplied consistent doses until they reached the maximum specified number. The 4 MDIs floated in the water in different ways and provided information when to replace for new ones in some MDIs.

Adolescent↗
PubMed1995

Aerosol particle generation from dry powder inhalers: can they equal pressurized metered dose inhalers?

In comparison with pressurized metered dose inhalers (pMDIs), dry powder inhalers (DPIs) emit a semi-stable aerosol cloud and are inspiratory flow actuated and inspiratory flow driven. In vitro studies show that different DPIs vary in their efficiency as delivery systems of fine drug particles (aerodynamic diameter < 5 microns). The efficiency of DPIs may vary according to the inspiratory force used to generate the aerosol. In comparison with other DPIs, Turbuhaler has been shown to be an efficient fine particle generator at weak, moderate and strong inspiratory forces. Deposition studies using human throat casts have shown that the throat has a minor influence on the deposition of drugs delivered from DPIs, whereas the throat has a major influence on the deposition of drug delivered from pMDIs. The fine particle dose able to penetrate the human throat casts was considerably higher for budesonide Turbuhaler than for budesonide pMDI, whereas for fluticasone propionate the fine particle dose was considerably higher from the pMDI than from Diskhaler. Thus, whether the fine particle dose and the deposition pattern of a drug generated from DPIs can equal that generated from pMDIs depends on the drug, the formulation and the patient.

Adult↗
PubMed1989

A double-blind comparison between a new multidose powder inhaler (Turbuhaler) and metered dose inhaler in children with asthma.

Turbuhaler is a ready-loaded multiple dose inhaler which does not require co-ordination between release of dose and inhalation. 57 children with asthma participated in this clinical trial to compare the clinical effect and acceptance of terbutaline sulphate via Turbuhaler with that of metered dose inhaler (MDI). The trial consisted of two parts. In the first part of the study, which made use of a double-blind cross-over design, the clinical effect and number of treatment occasions with Turbuhaler were compared with those of MDI. In the second part, which was open, all patients were treated with Turbuhaler for 2 weeks. At the end of this period the patients were asked to make a subjective assessment of effect and to state their preference. There was no difference in clinical effect and number of treatment occasions between Turbuhaler and MDI. A majority of the patients thought Turbuhaler had the best effect and was easy to use.

Adolescent↗
PubMed1997

Airway deposition and airway effects of antiasthma drugs delivered from metered-dose inhalers.

Many different metered-dose inhalation devices are becoming available for the treatment of airway diseases. Each of these inhalers differs in its delivery characteristics. An assessment of the efficacy of drug delivery by these inhalers is essential, in view of their therapeutic use. A review of the literature on the relationship between airway deposition and airway effects of drugs delivered from metered-dose inhalers is presented. Nebulizers or spacers are not discussed. The effect of an inhaler depends on the characteristics of the inhaler and the inhalation manoeuvre performed by the patient. This review focuses on the influence of inhaler characteristics on the airway deposition and airway effects. Data from several studies show that there is a significant relationship between the amount of drug deposited in the airways and the airway effects of the drug. Studies on the relationship between airway deposition and airway effect have been troubled by methodological problems, such as the absence of multiple dose comparisons and the difficulty in obtaining steep dose-response curves. The techniques for measuring airway deposition of inhaled drugs, namely the scintigraphic and the pharmacokinetic method, are discussed and compared. The appropriate use of these techniques can help to define and compare the drug delivery characteristics of different devices, thus enabling inhaled therapy to be optimized.

Administration, Inhalation↗
PubMed1994

Comparison of inhaled terbutaline administered by either the Turbuhaler dry powder inhaler or a metered-dose inhaler with spacer in preschool children with asthma.

We compared the bronchodilator response of terbutaline delivered either by a dry powder inhaler, the Turbuhaler, or by a metered-dose inhaler attached to a Nebuhaler inhaler in 10 children with stable asthma who were 3 to 6 years of age. The bronchodilator response did not differ between the two inhalational devices. The dry powder inhaler Turbuhaler is a suitable alternative to a metered-dose inhaler in the delivery of terbutaline to preschool children with stable asthma if adequate inhalational technique is used.

Administration, Inhalation↗
PubMed1995

Dose potency relationship of terbutaline inhaled via Turbuhaler or via a pressurized metered dose inhaler.

OBJECTIVE: The relative dose potency of cumulative doses of terbutaline sulfate inhaled via Turbuhaler and via a pressurized metered dose inhaler was estimated with respect to lung efficacy and systemic effect. METHODS: The study was an open, crossover, randomized, multicenter study including 31 adult patients with asthma [forced expiratory volume in one second (FEV1), 65% of predicted]. The patients inhaled terbutaline doses of 0.125, 0.125, 0.25, 0.5, 1.0, and 2.0 mg (a total of 4 mg) at 30-minute intervals. Lung function [FEV1, forced vital capacity (FVC), forced expiratory flow at 75% of FVC (FEF75%), and peak expiratory flow (PEF)], and systemic effect variables (serum potassium, tremor, pulse, blood pressure) were monitored prior to the first inhalation and 15 to 25 minutes after each inhaled dose. RESULTS: The mean relative dose potency of terbutaline inhaled via Turbuhaler compared with pressurized metered dose inhaler was 1.5 (95% confidence interval: 1.2 to 1.8) with respect to FEV1 and serum potassium, respectively. The corresponding relative dose potencies for PEF, FVC, and FEF75% were 1.0, 1.2, and 1.6, respectively, with no statistically significant difference between the two devices. No differences between the devices were evident with regard to blood pressure and pulse. CONCLUSION: The results suggest that Turbuhaler is more efficient in the delivery of inhaled terbutaline to the lungs compared with the conventional pressurized metered dose inhaler.

Administration, Inhalation↗
PubMed2001

Systematic review of clinical effectiveness of pressurised metered dose inhalers versus other hand held inhaler devices for delivering corticosteroids in asthma.

OBJECTIVE: To determine the clinical effectiveness of pressurised metered dose inhalers (with or without spacer) compared with other hand held inhaler devices for the delivery of corticosteroids in stable asthma. DESIGN: Systematic review of randomised controlled trials. DATA SOURCES: Cochrane Airways Group trials database (Medline, Embase, Cochrane controlled clinical trials register, and hand searching of 18 relevant journals), pharmaceutical companies, and bibliographies of included trials. TRIALS: All trials in children or adults with stable asthma that compared a pressurised metered dose inhaler with any other hand held inhaler device delivering the same inhaled corticosteroid. RESULTS: 24 randomised controlled trials were included. Significant differences were found for forced expiratory volume in one second, morning peak expiratory flow rate, and use of drugs for additional relief with dry powder inhalers. However, either these were within clinically equivalent limits or the differences were not apparent once baseline characteristics had been taken into account. No significant differences were found between pressurised metered dose inhalers and any other hand held inhaler device for the following outcomes: lung function, symptoms, bronchial hyper-reactivity, systemic bioavailability, and use of additional relief bronchodilators. CONCLUSIONS: No evidence was found that alternative inhaler devices (dry powder inhalers, breath actuated pressurised metered dose inhalers, or hydrofluoroalkane pressurised metered dose inhalers) are more effective than the pressurised metered dose inhalers for delivery of inhaled corticosteroids. Pressurised metered dose inhalers remain the most cost effective first line delivery devices.

Adult↗
PubMed2003

Comparison of the lung absorption of FK224 inhaled from a pressurized metered dose inhaler and a dry powder inhaler by healthy volunteers.

FK224 is a cyclopeptide drug with poor oral absorption due to proteolysis in the gastrointestinal tract. The objectives of this study were to investigate the absorption of FK224 from the lung in healthy volunteers, and compare the pharmacokinetic profiles of FK224 after inhalation from a pressurized metered dose inhaler (pMDI) and dry powder inhaler (DPI). The pMDI (Suspension type, 1 mg as FK224/puff) and DPI (4 mg and 10 mg as FK224/capsule, using Spinhaler as the device) were developed by formulating the same micronized particles of FK224 which were premixed with beta-cyclodextrin (beta-CyD) to improve the solubility of FK224. In the case of pMDI, 1, 4 or 8 mg was inhaled by the corresponding number of puffs with the pMDI. In addition, the in vitro drug delivery characteristics of the inhalers were evaluated using a multistage liquid impinger. In both inhalers, it was observed that FK224 could be absorbed into the systemic circulation from the lungs of the healthy volunteers, and the AUC and C(max) were proportionally increased depending on the emitted dose after inhalation. However, the pharmacokinetic (PK) parameters for DPI were significantly higher than that of pMDI, in spite of usage of the same fine particles for the formulations in both inhalers. Based on the distribution from the in vitro examination, the fine particle dose, which is defined as the dose region delivered as particles <3.8 microm, was calculated from the emitted dose inhaled by the healthy volunteers. It was found that the PK parameters for both inhalers were proportionally increased depending on the predicted fine particle dose regardless of the type of inhaler. This suggests that the absorption from the lung is influenced by the fine particle dose. We concluded that DPI is a suitable inhaler for FK224, and the alveolus, which is generally known as the site of action of the fine particles, is a possible absorptive site for FK224.

Administration, Inhalation↗
PubMed1991

Effect of a volumatic spacer and mouth rinsing on systemic absorption of inhaled corticosteroids from a metered dose inhaler and dry powder inhaler.

BACKGROUND: High doses of inhaled corticosteroids are absorbed systemically and may cause long term side effects. As rinsing the mouth out after use and inhaling through a spacing device may reduce systemic absorption this has been further investigated. METHODS: Three crossover studies were carried out to assess the effect of budesonide given by dry powder inhaler (Turbuhaler) with and without mouth rinsing and beclomethasone dipropionate given by metered dose inhaler with or without a spacing device (Volumatic) on serum cortisol concentrations and urinary cortisol excretion in patients with asthma taking an inhaled corticosteroid. Each treatment period was two weeks with in a two week washout period. Serum cortisol concentrations at 0800 hours on day 14 and the 24 hour urinary excretion of cortisol were measured. In study 1 24 patients taking beclomethasone dipropionate 500 micrograms twice a day inhaled with (n = 10) or without (n = 14) a Volumatic spacing device were switched to a budesonide dry powder inhaler, 600 micrograms to be taken twice a day without mouth rinsing. In study 2 10 patients took budesonide 800 micrograms twice a day with and without mouth rinsing and without swallowing the rinsing water. In study 3 17 patients took budesonide 800 micrograms twice daily with mouth rinsing and beclomethasone dipropionate 500 micrograms twice daily with the spacing device and mouth rinsing. RESULTS: In study 1 no difference was seen between budesonide without mouth rinsing and beclomethasone dipropionate without a spacer: beclomethasone with spacer caused less suppression of cortisol (mean (SD) serum cortisol concentration: beclomethasone and spacer 487(148), budesonide 368(145) nmol/l). In study 2 mouth rinsing caused less suppression of morning serum cortisol concentrations (rinsing 440(63), no rinsing 375(56) nmol/1). In study 3 there was no difference in serum or urinary cortisol concentrations between twice daily beclomethasone dipropionate 500 micrograms inhaled by Volumatic spacer or budesonide by Turbuhaler 800 micrograms twice daily, both with mouth rinsing. Individual serum cortisol values were within the normal range in all patients except one in study 1. CONCLUSION: Systemic absorption of a corticosteroid inhaled from a metered dose inhaler is reduced by using a spacing device and that from a dry powder inhaler by mouth rinsing.

Administration, Inhalation↗
PubMed1996

Efficacy and safety of inhaled bitolterol mesylate via metered-dose inhaler in children with asthma.

BACKGROUND: There have been numerous studies in asthmatic adults demonstrating the efficacy and safety of bitolterol mesylate metered-dose inhaler; however, only one additional study has examined bitolterol metered-dose inhaler in pediatric asthma. OBJECTIVE: To establish the safety and effectiveness of bitolterol mesylate metered-dose inhaler at one, two, and three inhalations in pediatric asthmatic patients 4 to 12 years of age. METHODS: A multicenter, double-blind, randomized, crossover, placebo-controlled, dose-ranging study. Forty-six patients were evaluated in three centers. Patients were stratified by age, 4 to 6, 7 to 9, 10 to 12 years at each center. One, two, or three inhalations were administered along with an additional double-blind, randomized, placebo dose. Bronchodilation was defined as a 15% or greater increase in FEV1 over baseline. Onset, maximum improvement, and duration of action were obtained for each patient. Serial pulse rate, blood pressure, and respiratory rate determinations were obtained for each patient. RESULTS: Onset within five minutes occurred in 56.6% to 71% of patients, depending on the dose. Mean maximum improvement, which was dose dependent, overall ranged from 28.2% to 40.3% with a peak response in 66.7 to 69.8 minutes. In direct relationship of magnitude with regard to dose of bitolterol was observed, (P < .001). A significant correlation, r = .732, in response between bronchodilation and baseline FEV1 was observed (P < .001). Median duration of action ranged from three to four hours in responding patients across all doses. Up to 31% of patients had durations greater than eight hours after three inhalations. Adverse effects were reported in five of 46 patients for all doses with mild transient tremor occurring in two patients, 4.3%. Also, there was little effect on pulse rate, 2.2%. CONCLUSION: Bitolterol is an effective bronchodilator with durations of activity up to eight hours and minimal adverse effects in children.

Administration, Intranasal↗
PubMed1991

Effects of inspirease holding chamber on the deposition of metered dose inhalation aerosols.

A modified cascade impaction method as well as a radiotracer technique has been used to assess the effects of the 700 ml collapsible holding chamber (InspirEase) on the in vitro and in vivo deposition of inhaled metered dose aerosols. The in vitro deposition of beclomethasone dipropionate 250 micrograms/dose aerosol administered either through the conventional aerosol actuator with the short plastic mouthpiece or through the InspirEase-device was evaluated with the modified cascade impactor which method imitated the human respiratory tract. For the in vivo study the disodium cromoglycate particles were labelled with pure gamma-radiator 99mTc using a coprecipitation technique based on spray drying. The deposition of the inhaled disodium cromoglycate particles in the human respiratory tract after administration of the drug doses from the devices tested was determined by means of gamma camera. InspirEase increased both in the in vitro and in vivo tests the fraction of the drug dose deposited into the therapeutically significant regions of the respiratory tract. In addition, the therapeutically insignificant fraction deposited in the upper passages and mouth clearly decreased. Thus using the InspirEase holding chamber not only a better lung penetration of the inhaled drug particles can be achieved but also the local side effects would be decreased.

Administration, Inhalation↗
PubMed2003

Results of a programme to improve house staff use of metered dose inhalers and spacers.

PURPOSE: Metered dose inhalers (MDIs) and spacers are used widely in the treatment of asthma. Medical personnel who are responsible for training patients must themselves be proficient with the devices. The proficiency of a group of new medical interns with use of MDI and spacer devices was determined, and improvement in their use of these devices was sought. SUBJECTS: Fifty six medical interns tested at the start of their first house staff training year. METHODS: The ability of medical interns to use MDIs and spacers was assessed using a visual scoring system before and after a large group lecture emphasising proper device use and once again after an intensive one-on-one training session with an attending physician. RESULTS: Initially, only 5% used an MDI perfectly. This improved to 13% after a lecture and demonstration, and 73% after an intensive one-on-one session. Almost no new interns could use a collapsible or tube spacer properly initially. This improved to 15% and 29% respectively after a lecture. After one-on-one training, correct technique was increased to 69% for collapsible spacer and 95% for the tube spacer. Analysis of individual steps of MDI use showed that interns had particular difficulty in coordinating actuation with inhalation. The tube spacer appeared easiest to learn. CONCLUSIONS: Incoming medical house staff have limited ability to use MDI with and without spacers. A large group lecture is relatively ineffective when compared with a one-on-one training session in training with these devices.

Asthma↗
PubMed1999

A critical comparison of the dose delivery characteristics of four alternative inhalation devices delivering salbutamol: pressurized metered dose inhaler, Diskus inhaler, Diskhaler inhaler, and Turbuhaler inhaler.

Salbutamol is a short-acting beta 2 agonist which is effective as a rescue therapy in the treatment of asthma. This study uses in vitro test methods to compare the capability of four alternative devices to deliver an accurate and precise dose of salbutamol. It is demonstrated that the conventional metered dose inhaler (MDI) achieves excellent accuracy and precision in dose delivery. Additionally, it is the most efficient inhaler in terms of generating in-vitro a fine particle fraction from the dose. A spacer device has been shown to further enhance the dosing characteristics. When tested over a wide range of inspiratory air flow rates, the Diskus (GlaxoWellcome, Hertfordshire, UK) has comparable accuracy and precision to the MDI tested at 60 L/min, and it offers an advantage over two alternative dry powder inhalers (DPIs), delivering a more consistent dose across the range of flow rates tested and being more efficient at generating a fine particle fraction than either Turbuhaler (Astra, Lund, Sweden) or Diskhaler (GlaxoWellcome) at both 28 and 60 L/min inspiratory flow rates. Diskus, Diskhaler, Ventolin, Volumatic, and Rotadisk are trademarks of the GlaxoWellcome Group of companies. The Accuhaler is the alternative to the Diskus in those countries where the Diskus trademark is not available. Inspiryl and Turbuhaler are trademarks of the Astra Group of companies.

Administration, Inhalation↗
PubMed1993

Nurses' performance of inhalation technique with metered-dose inhaler plus spacer device.

OBJECTIVE: To determine if nurses could correctly use a metered-dose inhaler plus spacer (MDI-spacer) device after a brief description and demonstration of proper use by a clinical pharmacist. DESIGN: Pretest, educational intervention, posttest. SETTING: University hospital. PARTICIPANTS: Twenty-three nurses. INTERVENTIONS: Nurses were asked to use the MDI-spacer (Aerochamber) and were scored using a nine-point checklist (pretest). Educational intervention by the clinical pharmacist consisted of a five-minute discussion and correct demonstration of the device. Nurses were then asked to use the device again (posttest). MAIN OUTCOME MEASURES: Pre- and posttest scores. RESULTS: Total scores were improved after the educational intervention (66 percent pretest vs. 88 percent posttest, p = 0.0001). In an item analysis, four of the nine steps had improved significantly. CONCLUSIONS: A brief discussion and demonstration of correct use of MDI-spacers is effective in improving nurses' skill in using the device.

Clinical Competence↗
PubMed1994

The rapid and effective administration of a beta 2-agonist to horses with heaves using a compact inhalation device and metered-dose inhalers.

The purpose of the study was to administer therapeutic aerosol generated by metered-dose inhalers to horses exhibiting clinical signs of heaves using a compact inhalation device developed for human medicine. It was fitted to a custom face mask in order to study the effect of an inhaled beta 2-agonist, fenoterol. Pulmonary function testing was performed on six horses following an acute exacerbation of heaves, characterized by tachypnea, wheezes, crackles, and spasmodic cough. Horses inhaled fenoterol in 1 mg increments administered as one 200 microgram puff every 5-10 s with the recording of data 5 min after the cessation of drug inhalation. A significant effect of fenoterol was shown for maximum change in transpulmonary pressure, dynamic compliance, lung resistance, and work of breathing, and the wheezes and crackles disappeared when auscultation was performed at the end of the test. This study demonstrates a novel, highly effective method for the rapid administration of inhaled medication in horses.

Administration, Inhalation↗